- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04877899
Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol
September 3, 2021 updated by: Ultromics Ltd
Mazankowski - Echo Go Discovery Protocol Retrospective LVEF/GLS Comparison
This study aims to compare conventionally acquired Left Ventricle Ejection Fraction (LVEF) and Global Longitudinal Strain (GLS) data to Artificial Intelligence (AI) driven automated processing of 2 dimensional contrast and 2 dimensional non-contrast resting transthoracic echocardiograms for application in the assessment of patients undergoing chemotherapy with cardiotoxic drugs.
This is a single-centre retrospective study which utilizes echocardiographic DICOM image and meta-data datasets received from a Canadian site.
Data processed using the AI driven automated processing will be compared to conventionally acquired LVEF and GLS measurements and results will be analysed to determine accuracy and precision.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2J2
- Mazankowski Alberta Heart Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Data included for analysis in this study will be retrospective data from male and female patients aged 18 years or above who received an echocardiogram for baseline and follow-up of cardiotoxic agent management, who agreed to participate in the echocardiography registry of the MAHI, and who have already provided a written consent that their anonymized imaging data can be used to advance echocardiographic assessment of LV function.
Description
Inclusion Criteria:
- Normal EF and no regional wall motion abnormalities prior to starting chemotherapy treatment.
- Follow-up EF measurements available for at least 1 year during the treatment period.
- Follow-up EF measurements for at least 1 year during the treatment period.
Exclusion Criteria:
- Age < 18 years
- Inadequate image quality (as determined by the Ultromics Operators Quality Control process)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.
Time Frame: Baseline
|
Measurements shall be compared using bias and 95% confidence intervals on bias.
Regression coefficients and comparative statistics will be employed for this objective.
|
Baseline
|
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms against conventional measurement acquisition.
Time Frame: Follow up (up to 1 year)
|
Measurements shall be compared using bias and 95% confidence intervals on bias.
Regression coefficients and comparative statistics will be employed for this objective.
|
Follow up (up to 1 year)
|
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.
Time Frame: Baseline
|
Measurements will be assessed using bias and 95% confidence internals on bias.
Regression coefficients, comparative statistics and equivalence testing might also be employed as a comparison measure for this objective.
|
Baseline
|
Compare the performance of automated EF and GLS measurements in resting transthoracic echocardiograms with and without the application of contrast agents.
Time Frame: Follow up (up to 1 year)
|
Measurements will be assessed using bias and 95% confidence internals on bias.
Regression coefficients, comparative statistics and equivalence testing might also be employed as a comparison measure for this objective.
|
Follow up (up to 1 year)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Harald Becher, Mazankowski Alberta Heart Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 8, 2020
Primary Completion (Actual)
March 31, 2021
Study Completion (Anticipated)
November 30, 2021
Study Registration Dates
First Submitted
April 22, 2021
First Submitted That Met QC Criteria
May 6, 2021
First Posted (Actual)
May 7, 2021
Study Record Updates
Last Update Posted (Actual)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 3, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COL-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
Clinical Trials on EchoGo
-
Ultromics LtdUniversity of Oxford; National Institute for Health Research, United Kingdom; Academic Health Science CentresActive, not recruitingCoronary Heart DiseaseUnited Kingdom